Effects Of Dry Needling On Mobility Among Children With Cerebral Palsy

NCT ID: NCT06661421

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2025-01-01

Brief Summary

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This study explores the potential of dry needling as a treatment for spasticity in the foot among children with cerebral palsy (CP). Dry needling involves inserting fine needles into specific trigger points or tight muscles without injecting any substances, aiming to relieve pain, improve muscle function, and promote tissue healing. In CP-related foot spasticity, dry needling may target hypertonic muscles, inducing a local twitch response that helps release muscle tension, reduce spasticity, and enhance overall muscle function. The technique may also stimulate sensory nerves and trigger the release of endorphins, contributing to pain relief and muscle relaxation.

While dry needling has shown effectiveness in reducing spasticity and improving muscle function in adults with conditions such as post-stroke, there is limited research on its benefits for children with CP. This randomized controlled trial aims to address this gap by evaluating the impact of dry needling on spasticity, range of motion, and functional mobility in children with CP.

Detailed Description

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The study will be conducted at Bliss Center of Care and Therapy in Faisalabad, involving 38 participants aged 6 to 12 years, all diagnosed with spastic cerebral palsy and classified under the Gross Motor Function Classification System (GMFCS) levels I-II. Participants will be divided into two groups: an experimental group receiving dry needling therapy (DNT) and routine physical therapy (RPT) and a control group receiving RPT only. Critical exclusion criteria include recent interventions, bleeding disorders, fixed joint deformities, recent seizures, Botulinum Toxin injections, or contraindications to dry needling.

Outcomes will be measured using the Wartenberg Pendulum Test, Active and Passive Ankle Dorsiflexion Range of Motion, and the Timed Up and Go Test, which will be assessed before and after a 10-week intervention. Data will be analyzed using SPSS version 23.0 to determine the efficacy of dry needling in managing spasticity in children with CP.

Conditions

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Cerebral Palsy (CP) Spasticity Range of Motion Functional Mobility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A sample size of 38 was calculated using Epitool online software, and the mean values of dynamic balance from the previous study were taken. By adding a 10% attrition rate (34+4), the sample size will be 38.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will get separate treatment protocols, and possible efforts will be put to mask both groups about the treatment.

Study Groups

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Dry Needling Group

Group A will receive Dry Needling Therapy (DNT) along with routine physical therapy. Each session includes a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, psoas stretching will be done prone, with assisted hip extension for 5 seconds and a 40-second hold, repeated five times. Strengthening exercises, including squats, heel rises, and step-ups with a loaded backpack, will target the lower extremities. The program lasts one month with three sessions per week, gradually increasing in intensity. Dry Needling (DN) uses 0.30 × 50 mm needles, applying the fast-in, fast-out technique for 1 minute per muscle. DN is done once per week for 10 weeks, with at least 48 hours between treatments.

Group Type EXPERIMENTAL

Dry Needling

Intervention Type DEVICE

This intervention combines Dry Needling Therapy (DNT) with routine physical therapy for children with spastic cerebral palsy. The experimental group will receive DNT alongside physical therapy, while the control group will undergo only physical therapy. Routine Physical Therapy includes a warm-up, stretching, and strengthening exercises like hamstring stretches and squats, adjusted over a month with increasing intensity. Dry Needling targets the gastrocnemius muscle using a fast-in, fast-out technique with sterile needles, applied weekly for 10 weeks. This combined approach aims to reduce spasticity, improve mobility, and enhance range of motion, distinguishing it from standard therapies.

Conventional Therapy Group

Sessions will include a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, a prone psoas stretch will involve assisted hip extension for 5 seconds, followed by a 40-second hold, repeated five times. Strengthening exercises like squats, heel raises, and step-ups with a loaded backpack will target the lower extremities. The program will last one month, with three weekly sessions focusing on hamstring stretches and progressive resistance exercises.

Group Type OTHER

Cerebral Palsy conventional Treatment

Intervention Type OTHER

Sessions will include a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, a prone psoas stretch will involve assisted hip extension for 5 seconds, followed by a 40-second hold, repeated five times. Strengthening exercises like squats, heel rises, and step-ups with a loaded backpack will target the lower extremities. The program will last one month, with three sessions per week, focusing on hamstring stretches and progressive resistance exercises.

Interventions

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Dry Needling

This intervention combines Dry Needling Therapy (DNT) with routine physical therapy for children with spastic cerebral palsy. The experimental group will receive DNT alongside physical therapy, while the control group will undergo only physical therapy. Routine Physical Therapy includes a warm-up, stretching, and strengthening exercises like hamstring stretches and squats, adjusted over a month with increasing intensity. Dry Needling targets the gastrocnemius muscle using a fast-in, fast-out technique with sterile needles, applied weekly for 10 weeks. This combined approach aims to reduce spasticity, improve mobility, and enhance range of motion, distinguishing it from standard therapies.

Intervention Type DEVICE

Cerebral Palsy conventional Treatment

Sessions will include a 5-minute warm-up, stretching, and strengthening exercises. Hamstring stretches will be done with the child supine, one leg flat, and the opposite hip flexed to 90°. Active knee extension will be held for 5 seconds, followed by a 40-second assisted stretch, repeated five times. If a short psoas is detected, a prone psoas stretch will involve assisted hip extension for 5 seconds, followed by a 40-second hold, repeated five times. Strengthening exercises like squats, heel rises, and step-ups with a loaded backpack will target the lower extremities. The program will last one month, with three sessions per week, focusing on hamstring stretches and progressive resistance exercises.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: 6 to 12 years old
* Walking ability at Gross Motor Function Classification System levels I to II
* Modified Modified Ashworth Scale (MAS) score higher than equal to 1 (score up to 2)
* Ability to understand and execute orders
* No ongoing rehabilitation intervention

Exclusion Criteria

* Recent introduction of a new intervention in addition to previous treatments
* Presence of bleeding disorders or skin conditions
* Skin sensitivity issues
* History of seizures within the past six months
* Previous administration of BTX-A injection within the last 6 months
* Presence of
* contraindications to dry needling
* Lack of consent to participate in the study
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maheen Ahmad Khan, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International Univerisity

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Ghannadi S, Shariat A, Ansari NN, Tavakol Z, Honarpishe R, Dommerholt J, Noormohammadpour P, Ingle L. The Effect of Dry Needling on Lower Limb Dysfunction in Poststroke Survivors. J Stroke Cerebrovasc Dis. 2020 Jun;29(6):104814. doi: 10.1016/j.jstrokecerebrovasdis.2020.104814. Epub 2020 Apr 21.

Reference Type BACKGROUND
PMID: 32327366 (View on PubMed)

Cruz-Montecinos C, Nunez-Cortes R, Bruna-Melo T, Tapia C, Becerra P, Pavez N, Perez-Alenda S. Dry needling technique decreases spasticity and improves general functioning in incomplete spinal cord injury: A case report. J Spinal Cord Med. 2020 May;43(3):414-418. doi: 10.1080/10790268.2018.1533316. Epub 2018 Oct 22.

Reference Type BACKGROUND
PMID: 30346254 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/24/0701

Identifier Type: -

Identifier Source: org_study_id

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